Graduated compression stockings to treat acute leg pain associated with proximal DVT

Susan R. Kahn; Stan Shapiro; Thierry Ducruet; Philip S. Wells; Marc A. Rodger; Michael J. Kovacs; David Anderson; Vicky Tagalakis; David R. Morrison; Susan Solymoss; Marie-José Miron; Erik Yeo; Reginald Smith; Sam Schulman; Jeannine Kassis; Clive Kearon; Isabelle Chagnon; Turnly Wong; Christine Demers; Rajendar Hanmiah; Scott Kaatz; Rita Selby; Suman Rathbun; Sylvie Desmarais; Lucie Opatrny; Thomas L. Ortel; Jean-Philippe Galanaud; Jeffrey S. Ginsberg

doi:10.1160/th14-05-0430

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2014; 112(06): 1137-1141
DOI: 10.1160/th14-05-0430

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

Graduated compression stockings to treat acute leg pain associated with proximal DVT

A randomised controlled trial

Susan R. Kahn

¹Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, Quebec, Canada

,

Stan Shapiro

¹Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, Quebec, Canada

²Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada

,

Thierry Ducruet

¹Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, Quebec, Canada

,

Philip S. Wells

³Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

,

Marc A. Rodger

³Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

⁴Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada

,

Michael J. Kovacs

⁵Division of Hematology, London Health Sciences Centre, London, Ontario, Canada

,

David Anderson

⁶Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada

⁷Capital Health, Halifax, Nova Scotia, Canada

,

Vicky Tagalakis

¹Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, Quebec, Canada

,

David R. Morrison

¹Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, Quebec, Canada

,

Susan Solymoss

⁸Division of Hematology, Montreal General Hospital, Montreal, Quebec, Canada

,

Marie-José Miron

⁹Department of Medicine, Hôpital Notre-Dame, Montreal, Quebec, Canada

,

Erik Yeo

¹⁰Division of Hematology, University Health Network, Toronto, Ontario, Canada

,

Reginald Smith

¹¹Divisions of Cardiology and Thrombosis, Victoria Heart Institute Foundation, Victoria, British Columbia, Canada

,

Sam Schulman

¹²Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada

¹³Karolinska Institute, Stockholm, Sweden

,

Jeannine Kassis

¹⁴Division of Hematology, HôpitalMaisonneuve-Rosemont, Montreal, Quebec, Canada

,

Clive Kearon

¹²Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada

,

Isabelle Chagnon

¹⁵Department of Medicine, Hôpital du Sacré-Coeur de Montréal/University of Montreal, Montreal, Quebec, Canada

,

Turnly Wong

¹⁶Department of Medicine, St. Boniface General Hospital/University of Manitoba, Winnipeg, Manitoba, Canada

,

Christine Demers

¹⁷Division of Hematology, CHU de Quebec, Quebec, Quebec, Canada

,

Rajendar Hanmiah

¹⁸Division of General Internal Medicine, St. Joseph’s Hospital, Hamilton, Ontario, Canada

,

Scott Kaatz

¹⁹Academic Hospital Medicine, Hurley Medical Center, Flint, Michigan, USA

,

Rita Selby

²⁰Departments of Medicine and Clinical Pathology, Sunnybrook Health Sciences Centre/University Health Network/University of Toronto, Toronto, Ontario, Canada

,

Suman Rathbun

²¹Vascular Medicine, Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma, USA

,

Sylvie Desmarais

²²Department of Medicine, Hôpital Pierre-Boucher, Longueil, Quebec, Canada

,

Lucie Opatrny

²³Vice-President Professional Services, St. Mary’s Hospital Center, Montreal, Quebec, Canada

,

Thomas L. Ortel

²⁴Division of Hematology, Duke University Medical Center, Durham, North Carolina, USA

,

Jean-Philippe Galanaud

²⁵Internal Medicine, Montpellier University Hospital, Montpellier, France

,

Jeffrey S. Ginsberg

¹²Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada

› Author Affiliations

Abstract

Summary

Acute deep venous thrombosis (DVT) causes leg pain. Elastic compression stockings (ECS) have potential to relieve DVT-related leg pain by diminishing the diameter of distended veins and increasing venous blood flow. It was our objective to determine whether ECS reduce leg pain in patients with acute DVT. We performed a secondary analysis of the SOX Trial, a multicentre randomised placebo controlled trial of active ECS versus placebo ECS to prevent the post-thrombotic syndrome.The study was performed in 24 hospital centres in Canada and the U.S. and included 803 patients with a first episode of acute proximal DVT. Patients were randomised to receive active ECS (knee length, 30–40 mm Hg graduated pressure) or placebo ECS (manufactured to look identical to active ECS, but lacking therapeutic compression). Study outcome was leg pain severity assessed on an 11-point numerical pain rating scale (0, no pain; 10, worst possible pain) at baseline, 14, 30 and 60 days after randomisation. Mean age was 55 years and 60% were male. In active ECS patients (n=409), mean (SD) pain severity at baseline and at 60 days were 5.18 (3.29) and 1.39 (2.19), respectively, and in placebo ECS patients (n=394) were 5.38 (3.29) and 1.13 (1.86), respectively. There were no significant differences in pain scores between groups at any assessment point, and no evidence for subgroup interaction by age, sex or anatomical extent of DVT. Results were similar in an analysis restricted to patients who reported wearing stockings every day. In conclusion, ECS do not reduce leg pain in patients with acute proximal DVT.

Keywords

Randomised controlled trial - venous thrombosis - stockings - compression - pain - placebos - therapeutics

Full Text

References

References
1 Pierson S, Pierson D, Swallow R. et al. Efficacy of graded elastic compression in the lower leg. J Am Med Assoc 1983; 249: 242-243.
2 Noyes LD, Rice JC, Kerstein MD. Hemodynamic assessment of high-compression hosiery in chronic venous disease. Surgery 1987; 102: 813-815.
3 Blattler W, Partsch H. Leg compression and ambulation is better than bed rest for the treatment of acute deep venous thrombosis. IntAngiol 2003; 22: 393-400.
4 Kahn SR, Shapiro S, Wells PS. et al. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet 2014; 383: 880-888.
5 Ginsberg JS, Hirsh J, Julian J. et al. Prevention and treatment of postphlebitic syndrome: results of a 3-part study. Arch Intern Med 2001; 161: 2105-2109.
6 Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs 2005; 14: 798-804.
7 Farrar JT, Young JP, LaMoreaux L. et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001; 94: 149-158.
8 Raju S, Hollis K, Neglen P. Use of Compression Stockings in Chronic Venous Disease: Patient Compliance and Efficacy. Ann Vasc Surg 2007; 21: 790-795.
9 Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres?. Pain 1997; /8 72: 95-97.